Aquestive Therapeutics to Report First Quarter 2021 Financial Results and Recent Business Highlights on May 4 and Host Confer...
April 21 2021 - 9:18AM
Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical
company focused on developing and commercializing differentiated
products that address patients’ unmet needs and solve therapeutic
problems, announced today that it will report results for first
quarter ended March 31, 2021 and provide an update on recent
developments in its business after market close on Tuesday, May 4,
2021.
Management will host a conference call for
investors at 8:00 a.m. ET on Wednesday, May 5, 2021. The conference
call can be accessed by dialing (866) 417-5886 from the U.S. and
(409) 217-8235 internationally, followed by the conference ID:
4455107.
There will also be a simultaneous, live webcast
available on the Investors section of the Company’s website at
https://investors.aquestive.com/events-and-presentations. The
webcast will be archived for 30 days.
About Aquestive
TherapeuticsAquestive Therapeutics is a pharmaceutical
company that applies innovative technology to solve therapeutic
problems and improve medicines for patients. The Company has
commercialized one internally-developed proprietary product to
date, Sympazan® (clobazam) oral film, has a commercial proprietary
product pipeline focused on the treatment of diseases of the
central nervous system, or CNS, and other unmet needs, and is
developing orally administered complex molecules to provide
alternatives to invasively administered standard of care therapies.
The Company also collaborates with other pharmaceutical companies
to bring new molecules to market using proprietary, best-in-class
technologies, like PharmFilm®, and has proven capabilities for drug
development and commercialization.
Forward-Looking
StatementCertain statements in this press release include
“forward-looking statements” within the meaning of the Private
Securities Litigation Reform Act of 1995. Words such as “believe,”
“anticipate,” “plan,” “expect,” “estimate,” “intend,” “may,”
“will,” or the negative of those terms, and similar expressions,
are intended to identify forward-looking statements. These
forward-looking statements include, but are not limited to,
statements regarding the advancement of Libervant™ and other
product candidates through the regulatory and development pipeline
and business strategies, market opportunities, and other statements
that are not historical facts. These forward-looking statements are
subject to the uncertain impact of the COVID-19 global pandemic on
our business including with respect to our clinical trials
including site initiation, patient enrollment and timing and
adequacy of clinical trials; on regulatory submissions and
regulatory reviews and approvals of our product candidates;
pharmaceutical ingredient and other raw materials supply chain,
manufacture, and distribution; sale of and demand for our products;
our liquidity and availability of capital resources; customer
demand for our products and services; customers’ ability to pay for
goods and services; and ongoing availability of an appropriate
labor force and skilled professionals. Given these uncertainties,
the Company is unable to provide assurance that operations can be
maintained as planned prior to the COVID-19 pandemic.
These forward-looking statements are based on
our current expectations and beliefs and are subject to a number of
risks and uncertainties that could cause actual results to differ
materially from those described in the forward-looking statements.
Such risks and uncertainties include, but are not limited to, risks
associated with the Company's development work, including any
delays or changes to the timing, cost and success of our product
development activities and clinical trials and plans for AQST-108,
AQST-109 and our other drug candidates; risk of delays in FDA
approval of our drug candidates Libervant, AQST-108, AQST-109 and
our other drug candidates or failure to receive approval; ability
to address the concerns identified in the FDA’s Complete Response
Letter dated September 25, 2020 regarding the New Drug Application
for Libervant; risk of our ability to demonstrate to the FDA
“clinical superiority” within the meaning of the FDA regulations of
Libervant relative to FDA-approved diazepam rectal gel and nasal
spray products including by establishing a major contribution to
patient care within the meaning of FDA regulations relative to the
approved products as well as risks related to other potential
pathways or positions which are or may in the future be advanced to
the FDA to overcome the seven year orphan drug exclusivity granted
by the FDA for the approved nasal spray product of a competitor in
the U.S. and there can be no assurance that we will be successful;
risk that a competitor obtains FDA orphan drug exclusivity for a
product with the same active moiety as any of our other drug
products for which we are seeking FDA approval and that such
earlier approved competitor orphan drug blocks such other product
candidates in the U.S. for seven years for the same indication;
risk inherent in commercializing a new product (including
technology risks, financial risks, market risks and implementation
risks and regulatory limitations); risk of development of our sales
and marketing capabilities; risk of legal costs associated with and
the outcome of our patent litigation challenging third party at
risk generic sale of our proprietary products; risk of sufficient
capital and cash resources, including access to available debt and
equity financing and revenues from operations, to satisfy all of
our short-term and longer term cash requirements and other cash
needs, at the times and in the amounts needed; risk of failure to
satisfy all financial and other debt covenants and of any default;
our and our competitors’ orphan drug approval and resulting drug
exclusivity for our products or products of our competitors;
short-term and long-term liquidity and cash requirements, cash
funding and cash burn; risk related to government claims against
Indivior for which we license, manufacture and sell Suboxone® and
which accounts for the substantial part of our current operating
revenues; risks related to the outsourcing of certain marketing and
other operational and staff functions to third parties; risk of the
rate and degree of market acceptance of our product and product
candidates; the success of any competing products, including
generics; risk of the size and growth of our product markets; risks
of compliance with all FDA and other governmental and customer
requirements for our manufacturing facilities; risks associated
with intellectual property rights and infringement claims relating
to the Company's products; risk of unexpected patent developments;
the impact of existing and future legislation and regulatory
provisions on product exclusivity; legislation or regulatory
actions affecting pharmaceutical product pricing, reimbursement or
access; claims and risks that may arise regarding the safety or
efficacy of the Company's products and product candidates; risk of
loss of significant customers; risks related to legal proceedings,
including patent infringement, investigative and antitrust
litigation matters; changes in government laws and regulations;
risk of product recalls and withdrawals; uncertainties related to
general economic, political, business, industry, regulatory and
market conditions and other unusual items; and other uncertainties
affecting the Company described in the “Risk Factors” section and
in other sections included in our Annual Report on Form 10 K, in
our Quarterly Reports on Form 10-Q, and in our Current Reports on
Form 8-K filed with the Securities Exchange Commission (SEC). Given
those uncertainties, you should not place undue reliance on these
forward-looking statements, which speak only as of the date made.
All subsequent forward-looking statements attributable to us or any
person acting on our behalf are expressly qualified in their
entirety by this cautionary statement. The Company assumes no
obligation to update forward-looking statements or outlook or
guidance after the date of this press release whether as a result
of new information, future events or otherwise, except as may be
required by applicable law.
PharmFilm®, Sympazan® and the Aquestive logo are
registered trademarks of Aquestive Therapeutics, Inc. All other
registered trademarks referenced herein are the property of their
respective owners.
Investor InquiriesWestwicke, an ICR
CompanyStephanie
Carringtonstephanie.carrington@westwicke.com646-277-1282
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